FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MALIS SURGICAL STOOL
K Number: K890309
·
Decision Feb 14, 1989
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
0
Applicant Total
27
Review Days
22
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Basic Information
- Device Name
- MALIS SURGICAL STOOL
- K Number
- K890309
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Valley Forge Scientific Corp.
- Date Received
- January 23, 1989
- Decision Date
- February 14, 1989
- Product Code
- FZM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FZM | Stool, Operating-Room | FDA class 1 | General, Plastic Surgery |
Other Clearances by Valley Forge Scientific Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K050364 | MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM | Mar 9, 2005 | Substantially Equivalent |
| K042604 | VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS | Oct 22, 2004 | Substantially Equivalent |
| K032601 | STRYKER INTERVENTIONAL PAIN RF GENERATOR | Apr 1, 2004 | Substantially Equivalent |
| K033499 | MALIS IRRIGATION MODULE 1000 | Nov 28, 2003 | Substantially Equivalent |
| K982229 | BI-DENT | Aug 13, 1998 | Substantially Equivalent |
| K973554 | VALLEY FORGE BIPOLAR BALL TIP ELECTRODE | Dec 19, 1997 | Substantially Equivalent |
| K971986 | VALLEY FORGE BIPOLAR LOOP | Aug 26, 1997 | Substantially Equivalent |
| K964143 | MINI-SYMM BIPOLAR COAGULATOR | Jan 9, 1997 | Substantially Equivalent |
| K955764 | VALLEY FORGE BIPLOAR LOOP | Mar 1, 1996 | Substantially Equivalent |
| K955346 | VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM | Dec 8, 1995 | Substantially Equivalent |